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Enrolling by Invitation

NCT Number: NCT07194967

Virtual Reality for Pain and Anxiety Relief in Labor

The aim of this study is to evaluate the impact of virtual reality hypnosis technique on pain and anxiety of women during labor. We will perform a randomized controlled trial on a group of labouring women at several hospitals in Tunis. We will also evaluate the satisfaction of women after the exposure to the virtual reality headset.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ben Arous regional Hospital

Ben Arous, 2096, Tunisia

About this study

This multicenter randomized controlled trial evaluates the effectiveness of a virtual reality hypnosis device (HypnoVR) in managing pain and anxiety during labor. Women in the latent and active phases of labor will be randomly assigned to either a VR intervention group or a control group receiving standard care.

Primary outcomes include pain level, measured using the Visual Analogue Scale (VAS), and anxiety level, assessed with the State-Trait Anxiety Inventory (STAI-Y). Both will be evaluated before and after the intervention.

Secondary outcomes include maternal vital signs (blood pressure and pulse), labor parameters (contraction frequency, duration, and intensity via NST), fetal parameters (heart rate and decelerations via Doppler), and maternal satisfaction (measured postpartum using a VAS satisfaction scale).

This study aims to determine whether HypnoVR can be an effective non-pharmacological method for improving the labor experience.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants must meet all of the following criteria to be eligible for inclusion in the study:

  • Female participants aged between 18 and 45 years
  • Primiparous or multiparous
  • Singleton pregnancy
  • Cephalic (vertex) presentation
  • Gestational age between 37 and 41 completed weeks
  • Admitted in spontaneous (uninduced) labor
  • Low-risk pregnancy with no obstetric complications (e.g., no preeclampsia, gestational diabetes, or intrauterine growth restriction)
  • Spontaneous and uneventful course of pregnancy
  • At least four documented prenatal care visits during pregnancy
  • Expressed desire for vaginal delivery
  • Provided written informed consent to participate in the study

Exclusion criteria

Participants will be excluded from the study if they meet any of the following criteria:

  • History of any psychiatric disorder (e.g., anxiety, depression, bipolar disorder, psychosis, delirium) organic brain disease, or cognitive/developmental disorders)
  • History of seizures or epilepsy
  • Any degree of hearing impairment
  • Any visual impairment
  • History of face, neck, or head injuries that may interfere with the use of virtual reality equipment
  • History of motion sickness or vestibular disorders (e.g., dizziness, vertigo)
  • Chronic pain conditions or frequent migraines
  • History of claustrophobia
  • High-risk pregnancy (e.g., fetal growth restriction, placenta previa, or other significant maternal-fetal complications)
  • Known fetal anomalies or placental abnormalities
  • Labor pain not attributed to uterine contractions
  • Induced labor (medically or pharmacologically initiated)

Treatment and study plan

Virtual Reality Hypnosis for Labor Pain and Anxiety Management

Device

For patients randomized to the intervention arm, the investigator will provide a clear explanation of the procedure and the use of the HypnoVR virtual reality headset. The investigator will remain present throughout the session to supervise the experience, using the companion tablet to monitor the visualization in real time.

Participants will be invited to select one of eight immersive visual environments designed to promote relaxation and analgesia during labor. Available options include: Tropical Beach, Underwood, Underwater Dive, Zen Garden, Astral Travel, Winter Landscape, Aurora Borealis, and Oasis.

Patients will be informed that they may discontinue the use of the headset at any time and for any reason, without any consequences for their standard medical care.

Primary outcomes

  1. pain level

    Time frame: Immediately before starting the intervention and immediately after completing the intervention

    The investigator assessed the pain level before and after the intervention using a Visual Analogue Scale VAS. The score ranges from 0 (no pain at all) to 10 (the worst pain imaginable).

  2. anxiety level

    Time frame: Immediately before starting the intervention and immediately after completing the intervention

    The investigator assessed the Anxiety level using the State Trait Anxiety Inventory (STAI) forme Y. The score ranges from 20 to 80 and higher scores are associated with higher levels of anxiety.

Secondary outcomes

  1. Blood pressure

    Time frame: Immediately before starting the intervention and immediately after completing the intervention, both systolic and diastolic blood pressures are mesures in millimetres of mercury (mmHg)

    Blood pressure in millimetres of mercury (mmHg)

  2. Pulse rate

    Time frame: Immediately before starting the intervention and immediately after completing the intervention

    pulse rate mesured in heart beat per minute (bpm)

  3. contractions intensity

    Time frame: Immediately before starting the intervention and immediately after completing the intervention

    contractions intensity is measured by NST machine, in millimiter of mercury (mmHg)

  4. Contraction frequency

    Time frame: Immediately before starting the intervention and immediately after completing the intervention

    Contraction frequency per 10 mn These measurements were made using an NST machine

  5. Contraction duration

    Time frame: Immediately before starting the intervention and immediately after completing the intervention

    contraction duration measured in minutes

  6. Patient's satisfaction

    Time frame: After giving birth postpartum within two hours (H2)

    Satisfaction will be assessed using the Visual Analog Scale for Satisfaction (VAS; 0 = not at all satisfied, 10 = completely satisfied), with higher scores indicating greater satisfaction

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Collaborators

  • HypnoVR

Registry information

Official study title

Effectiveness of Virtual Reality (HypnoVR) in Pain and Anxiety Management During Labor: Multicenter Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 26, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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